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Search / Trial NCT00446498

CPAP Versus NPPV in ACPE

Launched by OSPEDALE S. GIOVANNI BOSCO · Mar 12, 2007

Trial Information

Current as of April 30, 2025

Completed

Keywords

ClinConnect Summary

Background Although non-invasive ventilation has shown to be an effective treatment for acute cardiogenic pulmonary oedema (ACPO), literature still lacks of multi-centre randomised prospective studies that compares CPAP with NPPV.

Aim of the study was to assess efficacy and safety of CPAP and NPPV in patients with ACPO.

Methods 80 patients with ACPO were randomly assigned to receive CPAP or NPPV (40 for each group) through a face mask.

Inclusion criteria were: severe dyspnoea, respiratory rate \> 30, PaO2/FiO2 \< 200, muscle fatigue.

Main end-points were endotracheal intubation, length ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • rapid onset of the symptoms
  • severe dyspnoea at rest
  • respiratory rate \> 30 breath per minute
  • use of accessory respiratory muscles
  • PaO2/FiO2 \< 200, radiological findings of ACPE
  • Exclusion Criteria:
  • ST elevation myocardial infarction
  • hemodynamic instability (systolic arterial pressure \< 90 mmHg
  • need for immediate endotracheal intubation (respiratory arrest, bradypnea
  • inability to protect the airways, impaired sensorium (agitation or unconsciousness
  • inability to clear secretions, respiratory tract infections
  • chronic obstructive pulmonary disease (COPD) exacerbation, chronic respiratory failure necessitating long-term oxygen therapy
  • pulmonary embolism, pneumonia, recent oesophageal-gastric surgery
  • gastrointestinal bleeding
  • facial deformities
  • haematological malignancy or cancer with Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.

About Ospedale S. Giovanni Bosco

Ospedale S. Giovanni Bosco is a distinguished healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. Located in Turin, Italy, the hospital is renowned for its commitment to high-quality patient care and its robust research capabilities across various therapeutic areas. By collaborating with a diverse network of clinical experts and leveraging state-of-the-art facilities, Ospedale S. Giovanni Bosco actively contributes to the development of new treatments and therapies, fostering an environment of scientific excellence and patient-centered care.

Locations

Torino, , Italy

Patients applied

0 patients applied

Trial Officials

Giovanni Ferrari, MD

Principal Investigator

Ospedale San Giovanni Bosco ASL4

Giovanni Ferrari, MD

Principal Investigator

Ospedale San Giovanni Bosco ASL4 Torino Italy

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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